Post

Format for Clinical Data Presentations in Orthopedic Implant Device Submissions

This guidance provides recommended formats for presenting clinical data in premarket notifications (510(k)s), IDE annual progress reports, PMA applications, and annual/post-approval study reports specifically for orthopedic implant devices. It aims to standardize data presentations to facilitate review but does not cover preclinical data presentation requirements.

  1. Develop standardized data collection forms aligned with recommended presentation formats
  2. Establish clear definitions for subsequent surgical interventions in IDE protocol
  3. Implement tracking system for patient follow-up to maintain minimum 85% rate
  4. Create detailed adverse event reporting process including categorization system
  5. Define success/failure criteria for surgical interventions in study protocol
  6. Establish process for separate tracking of protocol deviation cases
  7. Develop templates for demographic data collection aligned with recommended tables
  8. Create system for tracking effectiveness parameters over time
  9. Implement process for documenting and categorizing all adverse events
  10. Establish procedure for narrative documentation of adverse events and surgical interventions

Key Considerations

Clinical testing

  • Minimum 85% follow-up rate recommended for each study cohort
  • Clear description of evaluation intervals pre/post-treatment with defined follow-up windows
  • Patient accounting must track theoretical follow-up, deaths, failures, expected and actual follow-up
  • Time course distributions of effectiveness parameters (pain, function, radiographic assessments, etc.)
  • Individual patient success rates over time

Safety

  • Record and report all preoperative, operative, and postoperative complications
  • Categorize adverse events as device-related, operative site-related, and systemic
  • Track subsequent secondary surgical interventions (revisions, removals, reoperations, supplemental fixations)
  • Provide detailed narratives for adverse events

Other considerations

  • WHO International Classification Systems: International Classification of Diseases
  • WHO International Classification Systems: International Classification of Impairments, Disability and Handicaps

Original guidance

  • Format for Clinical Data Presentations in Orthopedic Implant Device Submissions
  • HTML / PDF
  • Issue date: 2004-12-01
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 54ee0e8785f6bd18e624abb0a97ad2d4
This post is licensed under CC BY 4.0 by the author.